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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER?; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER?; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493925128400
Device Problems Bent (1059); Fracture (1260); Difficult to Insert (1316)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported that stent damage and stent fracture occurred.A 28 x 4.00 promus premier¿ drug-eluting stent was selected to treat the target lesion.However, the physician could not get the device into the guide catheter.After examining the stent, the physician noted that some struts on the stent were fractured and some metal was sticking out.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device is a combination product.(b)(4).
 
Manufacturer Narrative
Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found stent struts on the 6th row from the proximal end of the crimped stent were lifted upwards from the stent profile.An examination of the crimped stent found no stent strut fractures evident.The bumper tip of the device showed no signs of damage.The balloon cone profiles were reviewed and no issues were noted with the overall balloon profile.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination found multiple kinks along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination found that the inner wire lumen and outer shaft were damaged at the location of the bi-component bond.The damage evident may have prevented the tracking of the device over the guidewire during the procedure; however the device was successfully tracked over the guidewire during examination of the unit.The damage may have been caused by the product mandrel or guidewire while being tracked over by the device.There is no evident damage to the bi-component bond.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
It was reported that stent damage and stent fracture occurred.A 28 x 4.00 promus premier¿ drug-eluting stent was selected to treat the target lesion.However, the physician could not get the device into the guide catheter.After examining the stent, the physician noted that some struts on the stent were fractured and some metal was sticking out.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
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Brand Name
PROMUS PREMIER?
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4587019
MDR Text Key5342102
Report Number2134265-2015-01269
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
P110010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2016
Device Model NumberH7493925128400
Device Catalogue Number39251-2840
Device Lot Number17262200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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